Abiraterone Impurity 19 (CAS 2307194-37-0) es una impureza identificada en procesos sintéticos de abiraterona que requiere caracterización rigurosa por su impacto potencial en la calidad del principio activo. Se recomienda su análisis mediante HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. Su perfil físicoquímico y niveles deben incluirse en especificaciones de calidad | con límites basados en guías ICH Q3A y estudios de cualificación de impurezas. La evaluación de su estabilidad | efectos en potencia y seguridad y la implementación de controles de proceso y procedimientos de purificación son críticos para garantizar cumplimiento regulatorio.
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